InfertilityNCT03717441
DNA Analysis of Discarded Media Drops From the Clinical IVF Cycles
An observational study of Infertility, run by Colorado Center for Reproductive Medicine at 1 site in United States.
Trial summary
Performing DNA analysis of discarded media drops from the clinical IVF cycles completed in our Center Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- chromosome numeration of embryos
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2018to 15 Jun 2026
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Recruiting women undergoing In Vitro Fertilization with Comprehensive Chromosomal Screening of embryos
Who may be able to join
- Any women undergoing an In Vitro Fertilization cycle (IVF) at the Colorado Center for Reproductive Medicine that is also having Comprehensive Chromosomal Screening (CCS) of embryos
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, 80124
Rachel Makloski, RN, rmakloski@colocrm.com
About this study
Performing DNA analysis of discarded media drops from the clinical IVF cycles completed in our Center
Read the detailed description
The purpose of this research study is to investigate for the presence of DNA in the surrounding media that is remaining after human clinical IVF cycles, to have a non-invasive way of obtaining markers of embryo chromosome numeration. Media recovered from the clinical IVF laboratory is typically discarded during an IVF cycle. Genomic technologies will be used to analyze the otherwise discarded media drop for chromosome counting.
- Conditions
- Infertility
- Being tested
- chromosome numeration of embryos
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chromosome numeration of embryosDiagnostic test
Use genomic technologies to analyze the discarded media drop for chromosome counting
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA Analysis of discarded media drops form the clinical IVF Cycles
Analyze media drop for presence of DNA to obtain embryo chromosome numeration
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start22 Oct 2018
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Colorado Center for Reproductive Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandy Katz-Jaffe, Colorado Center for Reproductive Medicine
- Investigators
- Mandy Katz-Jaffe, PhD, Principal investigator, Colorado Center for Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717441
- Sponsor's protocol ID
- 2018154
- Status last verified
- Feb 2024
- First submitted
- 22 Oct 2018
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Analysis of Discarded Media Drops From the Clinical IVF Cycles
- ClinicalTrials.gov ID
- NCT03717441
- Acronym / sponsor ID
- 2018154
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Colorado Center for Reproductive MedicineUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Performing DNA analysis of discarded media drops from the clinical IVF cycles completed in our Center
Detailed description
The purpose of this research study is to investigate for the presence of DNA in the surrounding media that is remaining after human clinical IVF cycles, to have a non-invasive way of obtaining markers of embryo chromosome numeration. Media recovered from the clinical IVF laboratory is typically discarded during an IVF cycle. Genomic technologies will be used to analyze the otherwise discarded media drop for chromosome counting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Recruiting women undergoing In Vitro Fertilization with Comprehensive Chromosomal Screening of embryos
Key inclusion criteria (1 listed)
- Any women undergoing an In Vitro Fertilization cycle (IVF) at the Colorado Center for Reproductive Medicine that is also having Comprehensive Chromosomal Screening (CCS) of embryos
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chromosome numeration of embryosUse genomic technologies to analyze the discarded media drop for chromosome counting | Diagnostic test | – |
Primary outcome
DNA Analysis of discarded media drops form the clinical IVF Cycles
Time frame: 1 day
Analyze media drop for presence of DNA to obtain embryo chromosome numeration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mandy Katz-Jaffe, PhD principal investigator
Colorado Center for Reproductive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Colorado Center for Reproductive Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Makloski (303-788-8300 ext. 1769, rmakloski@colocrm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA Analysis of discarded media drops form the clinical IVF Cycles (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.